PALONOSETRON QILU 250 micrograms Injectable Solution

Introduction

Package Leaflet: Information for the Patient

Palonosetron Qilu 250 micrograms solution for injection EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• • If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Palonosetron Qilu and what is it used for
2. What you need to know before you use Palonosetron Qilu
3. How to use Palonosetron Qilu
4. Possible side effects
5. Storage of Palonosetron Qilu
6. Contents of the pack and other information

1. What is Palonosetron Qilu and what is it used for

Palonosetron belongs to a group of medicines called serotonin (5-HT3) antagonists, which have the ability to block the action of the chemical compound serotonin (which can cause nausea and vomiting).

Palonosetron is used in the prevention of nausea and vomiting associated with anti-cancer chemotherapy in adults, adolescents, and children over one month of age.

2. What you need to know before you use Palonosetron Qilu

Do not usePalonosetron Qilu:

• if you are allergic to palonosetron or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use palonosetron:

• If you have acute intestinal obstruction or a history of repeated constipation.
• If you are using palonosetron in addition to other medicines that may cause an abnormal heart rhythm, such as amiodarone, nicardipine, quinidine, moxifloxacin, erythromycin, haloperidol, chlorpromazine, quetiapine, thioridazine, or domperidone.
• If you have a personal or family history of heart rhythm disorders (prolongation of the QT interval).
• If you have other heart disease.
• If you have an imbalance of certain minerals in the blood, such as potassium and magnesium, that has not been treated.

Palonosetron should not be used in the days following chemotherapy, unless you are receiving another cycle of chemotherapy.

UsingPalonosetronQiluwith other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including:

SSRIs (selective serotonin reuptake inhibitors) used to treat depression or anxiety, which include fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram.

SNRIs (serotonin and norepinephrine reuptake inhibitors) used to treat depression or anxiety, which include venlafaxine and duloxetine.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or think you may be pregnant, your doctor will not give you palonosetron unless it is clearly necessary. It is not known if palonosetron can cause any harmful effects if used during pregnancy.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Breast-feeding

It is not known if palonosetron is excreted in breast milk. If you are breast-feeding, ask your doctor or pharmacist for advice before taking palonosetron.

Driving and using machines

Palonosetron may cause dizziness or fatigue. If you experience any of these effects, do not drive or use tools or machines.

Palonosetron Qilucontainssodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially 'sodium-free'.

3. How to use Palonosetron Qilu

Normally, a doctor or nurse will inject palonosetron about 30 minutes before starting chemotherapy.

Adults

The recommended dose of palonosetron is 250 micrograms, given as a rapid injection into a vein.

Children and adolescents (from 1 month to 17 years of age)

The doctor will decide the dose based on body weight. However, the maximum dose is 1500 micrograms.

Palonosetron will be given as a slow infusion into a vein.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:

Adults

Common (may affect up to 1 in 10 people)

• headache, dizziness, constipation, and diarrhea

Uncommon (may affect up to 1 in 100 people)

• hypertension or hypotension
• abnormal heart rhythm or lack of blood flow to the heart
• change in the color of the vein or the veins becoming enlarged
• abnormally high or low levels of potassium in the blood
• high levels of sugar in the blood or sugar in the urine
• low levels of calcium in the blood
• high levels of the pigment bilirubin in the blood
• high levels of certain liver enzymes
• elevated mood or feeling of anxiety
• drowsiness or sleep problems
• decreased or loss of appetite
• weakness, fatigue, fever, or flu-like symptoms
• numbness, burning sensation, itching, or tingling sensation on the skin
• pruritic rash
• vision changes or eye irritation
• motion sickness
• ringing in the ears
• hypo, flatulence, dry mouth, or indigestion
• abdominal pain (stomach)
• difficulty urinating
• joint pain
• abnormalities in the electrocardiogram (prolongation of the QT interval)

Rare (may affect up to 1 in 10,000 people)

• Allergic reactions to palonosetron

Signs of an allergic reaction may include swelling of the lips, face, tongue, or throat, difficulty breathing, or collapse; you may also notice itching, hives, burning, or pain at the injection site

Children and adolescents:

Common (may affect up to 1 in 10 people):

• headache

Uncommon (may affect up to 1 in 100 people):

• dizziness
• muscle spasms
• abnormal heart rhythm
• cough or difficulty breathing
• nasal bleeding
• pruritic rash or hives
• fever
• pain at the infusion site

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Palonosetron Qilu

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiry date refers to the last day of the month shown.

Store the vial in the outer packaging to protect it from light.

For single use only. Any unused solution should be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition ofPalonosetron Qilu

• The active substance is palonosetron (as hydrochloride).

Each milliliter of solution contains 50 micrograms of palonosetron. Each 5 ml vial contains 250 micrograms of palonosetron.

• The other ingredients are mannitol, sodium citrate, citric acid monohydrate, and water for injections.

Appearance and packaging

Palonosetron Qilu solution for injection is a clear and colorless solution and is presented in a carton containing a 6 ml type I glass vial with a bromobutyl rubber stopper and a 20 mm aluminum and plastic cap, containing 5 ml of solution. Each vial contains one dose.

It is presented in packs of 1 vial containing 5 ml of solution.

Marketing authorization holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

8th floor, Madrid, 28046,

Spain

Manufacturer

Netpharmalab Consulting Services

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid

Spain

and

Kymos, S.L.

Ronda de Can Fatjó,

7B (Parque Tecnológico del Vallès),

Cerdanyola del Vallès, 08290

Barcelona, Spain

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: 02/2017

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/